First FDA-certified Apple Watch accessory is AliveCor's Kardia Band EKG meter

After a few years of health monitor peripherals availability lacking the Food and Drug Administration's approval, AliveCor's Kardia Band has been approved by the agency, opening up more use of the device in diagnoses of atrial fibrillation in the United States.

Available in Europe for a year and just now released in the U.S., the Kardia Band is activated by the user placing a finger on the sensor pad. The measurement taken across the finger to the Apple Watch facilitates the 30-second EKG reading.

Acoustical signals transmit the reading to the Apple Watch, with it displayed as a waveform on the watch. The data is stored on the connected iPhone.

Clearance granted by the FDA allows the software and hardware combination to advise the wearer that the reading is normal, or possibly an indication of atrial fibrillation.

The subscription service connected to the hardware, SmartRhythm, examines real-time and historical data to predict what is considered acceptable for heart rate readings. Should the user's heart rate exceed that range too many times a day or for a long period of time, the app tells the user to take a EKG reading.

"A lot of my patients already use the credit card sensor, but they don't know when to take an EKG; so they just do it when they feel light-headed or dizzy," Scripps cardiologist Dr. Eric Topol told FastCompany. ""If you can direct them when to do the EKG it's going to markedly increase the number of EKGs taken."

Atrial fibrillation is a change in the normal rhythm of the heart characterized by irregular beat, which is generally imperceptible by the sufferer. The disease is associated with a significantly higher rate of heart failure, stroke, and is linked to dementia as well.

Between two and three percent of North Americans and Europeans are affected by the disease. Four percent of people between 60 and 70 are afflicted, with the number rising to 14 percent of those over 80 years of age.

Atrial fibrillation was responsible for 193,000 deaths in 2015.

AliveCor's Kardia Band is available now for $199, for either the 38mm or 42mm Apple Watch. The Kardia Band replaces the Apple Watch band.

The device requires subscription to AliveCor's premium service for $99 a year, with one free month of service included.

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11 Comments

techno 737 comments · 20 Years

About 6 years ago

This is where the watch takes a very important path. With more FDA approved devices like this, the value of the Apple Watch significantly improves for the non-fanboys.

SendMcjak 66 comments · 7 Years

Acoustical signals transmit the reading to the Apple Watch, with it displayed as a waveform on the watch. The data is stored on the connected iPhone.

Do I have this straight? The band (power source?) uses a speaker to create audio waveforms that carry data to the Apple Watch's microphone?

So much for the diagnostic port being used for more elegant band--watch data transfer.

Note to AI: acoustical signals are transmitted (and, thus, carry) the readings ... super weird to say the "signals transmit"...

rogifan_new 4297 comments · 9 Years

techno said:

This is where the watch takes a very important path. With more FDA approved devices like this, the value of the Apple Watch significantly improves for the non-fanboys.

I’m still a bit confused how this is utilizing the Watch. Could they just make a band that communicated with your phone? I think these things will be a tough sell if they add another $200 to the price of an Apple Watch. Unless they’re subsidized by your health insurance company.

foggyhill 4767 comments · 10 Years

rogifan_new said:

techno said:

This is where the watch takes a very important path. With more FDA approved devices like this, the value of the Apple Watch significantly improves for the non-fanboys.

I’m still a bit confused how this is utilizing the Watch. Could they just make a band that communicated with your phone? I think these things will be a tough sell if they add another $200 to the price of an Apple Watch. Unless they’re subsidized by your health insurance company.

Medical devices are very expensive and you'd be surprised how much any one who actually needs it will pay for them.
Devices that otherwise should cost $100 bucks cost $1000 if they are "FDA approved", so $200 is no biggie.
This is an area ripe for disruption. Apple taking care of the data management / display / storage means those medical device makers could concentrate on something they're actually good at (the medical aspect) and not everything else, which they are undoubtedly they are not.

GG1 483 comments · 7 Years

foggyhill said:

rogifan_new said:

techno said:

This is where the watch takes a very important path. With more FDA approved devices like this, the value of the Apple Watch significantly improves for the non-fanboys.

I’m still a bit confused how this is utilizing the Watch. Could they just make a band that communicated with your phone? I think these things will be a tough sell if they add another $200 to the price of an Apple Watch. Unless they’re subsidized by your health insurance company.

Medical devices are very expensive and you'd be surprised how much any one who actually needs it will pay for them.
Devices that otherwise should cost $100 bucks cost $1000 if they are "FDA approved", so $200 is no biggie.
This is an area ripe for disruption. Apple taking care of the data management / display / storage means those medical device makers could concentrate on something they're actually good at (the medical aspect) and not everything else, which they are undoubtedly they are not.

Exactly. Besides the high cost for FDA approval, there is also the long approval time required. Niche medical companies can thrive in this (Apple Watch) environment. These medical "accessories" aren't quickly or easily copied.